Verifying Raw Materials Using Spatially Offset Raman Spectroscopy

Significance of the Topic

The identification of raw materials in pharmaceutical manufacture is critical for patient safety and regulatory compliance. Spatially offset Raman spectroscopy (SORS) offers a rapid, noninvasive approach to verify material identity inside sealed or opaque containers. This technique reduces resource demands and preserves sample integrity in QC workflows.

Objectives and Study Overview

This technical overview explains the principles of SORS and demonstrates its application for raw material identity verification (RMID) in pharmaceutical and biopharmaceutical settings. It highlights the benefits of in situ analysis through various packaging types and outlines system performance using Agilent SORS instruments.

Methodology and Instrumentation

SORS employs two Raman measurements at different laser excitation offsets on the container surface. A zero offset spectrum captures container signal, while an offset measurement probes the underlying contents. Scaled subtraction removes container contributions, isolating the sample spectrum for comparison to reference databases.

• Agilent Vaya Raman system: handheld SORS device for rapid ID through clear vials, tubs, sacks and amber glass
• Agilent RapID Raman system: portable wheeled unit optimized for challenging opaque containers including paper sacks, FIBCS and PE tubs

Key Results and Discussion

SORS enabled clear identification of sucrose through a 1.5 mm thick polypropylene container in under ten seconds, where conventional Raman failed due to container opacity and fluorescence. Multi-layer paper, colored plastics and glass also yielded high quality spectra, demonstrating robust container interference removal and accurate material matching.

Benefits and Practical Applications

• Eliminates the need to open or sample containers, reducing risk and clean up
• Supports 100 percent ID compliance with minimal handling and rapid throughput
• Maintains sterility and shelf life of sensitive materials such as surfactants and media blends
• Enables multi-point survey scanning on a single container for thorough analysis
• Accommodates a wide range of container types and material chemistries

Future Trends and Opportunities

Advances in SORS may include integration with automated sampling robots, enhanced spectral processing with machine learning algorithms, and expanded spectral libraries for novel materials. Miniaturized and networked SORS sensors could enable continuous in line monitoring of raw materials and real time QC feedback.

Conclusion

Spatially offset Raman spectroscopy transforms pharmaceutical raw material verification by enabling rapid, noninvasive analysis through opaque packaging. With handheld and portable Agilent SORS systems, QC workflows gain efficiency, preserve sample integrity and ensure regulatory compliance.

References

None provided in the source document.